Korean J Gastroenterol.  2025 Jan;85(1):64-72. 10.4166/kjg.2024.140.

Long-Term Real-World Outcomes of Tenofovir Alafenamide in Chronic Hepatitis B: Detailed Analysis of Treatment-Naive and Experienced Patients

• Song YX
• Song GJ
• Ma H
• Feng B
• Xie YD

• KMID: 2565016
• DOI: http://doi.org/10.4166/kjg.2024.140

Abstract

Background/Aims
This study assessed the long-term efficacy and safety of tenofovir alafenamide (TAF) in real-world settings.
Methods
Patients who were candidates for TAF treatment and were followed up at 12-week intervals over 192 weeks were enrolled in this study.
Results
One hundred and forty-four patients (50 treatment-naive and 94 treatment-experienced) were included in this study. The cumulative incidence rates of cirrhosis and hepatocellular carcinoma at 192 weeks were 3.9% and 0.7%, respectively. In treatment-naive patients, the rates of a virological response, HBeAg conversion, and HBsAg loss at 192 weeks were 100%, 33.3%, and 2%, respectively. The treatment-naive patients exhibited higher baseline HBsAg levels than the treatment-experienced patients (4.31 log₁₀IU/mL vs. 3.97 log₁₀IU/mL). A significant decrease in the HBsAg levels from the baseline was observed at 144 and 192 weeks in the treatment-naive patients (p=0.01). The baseline body mass index (BMI) <25 kg/m² (p=0.02) and HBsAg <3.3 log₁₀IU/mL (p=0.04) were identified as predictive factors for a decrease in HBsAg ≥0.5 log₁₀IU/mL at 48 weeks. The eGFR levels were consistently lower in the treatment-experienced patients throughout the study. Although the treatment-naive patients showed no abnormal increases in urinary URBP, the treatment-experienced patients showed elevated urinary β2MG and NAG levels at the baseline, which decreased over the treatment course. The total cholesterol, triglyceride, and low-density lipoprotein levels were similar in both groups.
Conclusions
Prolonging the TAF treatment duration enhances the virological response rate. The decline in HBsAg levels was more significant in the treatment-naive patients than in the treatment-experienced patients. The baseline BMI <25 kg/m² and HBsAg <3.3 log₁₀IU/mL were predictive factors for a significant decline in HBsAg at 48 weeks. TAF has high renal safety and no significant impact on lipid levels.

Keyword

Chronic hepatitis B; Tenofovir; Efficacy; Kidney injury

Figure

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  Fig. 1 Virological response of the treatment-naive patients.

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  Fig. 2 Effect of TAF on HBsAg in treatment-naive and treatment-experienced patients. TAF, tenofovir alafenamide; HBsAg, hepatitis B surface antigen.

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  Fig. 3 Effect of TAF on renal function. (A) Effect of TAF on eGFR. (B) Effect of TAF on URBP. (C) Effect of TAF on β2MG. (D) Effect of TAF on NAG. TAF, tenofovir alafenamide; eGFR, estimated glomerular filtration rate; URBP, urinary tests for retinol-binding protein; β2MG, β2-microglobulin; NAG, N-acetyl-β-D-glucosaminidase.

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  Fig. 4 Effect of TAF on blood lipids. TAF, tenofovir alafenamide; TC, total cholesterol; LDL, low-density lipoprotein; TG, triglyceride.

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